AstraZeneca Jobs | Employment For Quality Supplier Manager Careers in Gaithersburg, Maryland

AstraZeneca Jobs – Quality Supplier Manager Jobs in Gaithersburg, Maryland. AstraZeneca Jobs in Gaithersburg. Latest USA Government Jobs. Get City of Gaithersburg Jobs in USA. Upcoming USA Govt Jobs.

Maryland Jobs Seekers who are looking for Quality Supplier Manager Jobs in Gaithersburg, can check here Maryland Government Jobs in AstraZeneca. AstraZeneca Jobs opportunity available for Quality Supplier Manager Jobs in United State Of America.

Candidates who have PhD qualification eligibility Quality Supplier Manager position can apply through the AstraZeneca Jobs page link provides in the below section. You can check on this page all upcoming Quality Supplier Manager jobs in AstraZeneca and other jobs in Maryland.


AstraZeneca Jobs – Apply for Quality Supplier Manager Jobs In Gaithersburg, Maryland

AstraZeneca Jobs in Gaithersburg:– Great news for job seekers. AstraZeneca Jobs site publish notice for various jobs vacancy in their offices. Currently AstraZeneca Quality Supplier Manager Jobs available now. Candidates who are looking for Quality Supplier Manager Jobs in Gaithersburg with relevant required experience can apply for AstraZeneca Jobs Employment. Candidate will get after selection great Salary $152,500.00 per year.

AstraZeneca Jobs in Gaithersburg Employment 

Name of the Recruitment Agencies/ Department: AstraZeneca

Name of the Vacant Position: Quality Supplier Manager

Job Location: Gaithersburg

Jobs Type: Jobs in Maryland

Salary: $152,500.00 per year

Full Job Description

At AstraZenecawe work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.In this role as a SupplierQuality Specialist, you will be performing supplier qualification and oversight of external companies.Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 specialists in our field, and is only a short drive from Washington, DC. It is filled with ground breaking technology. Our lab spaces were built to facilitate collaboration, interaction and cross functional science.We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours.The Gaithersburg site offer a variety of amenities to help boost efficiency and to keep our employees happy and balanced. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.Join AstraZeneca and help us deliver life changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in Biopharmaceuticals.

Main Responsibilities:

  • Perform supplier qualification and monitoring and associated activities (risk assessments, investigations, complaint handling, etc.) to maintain license to operate and availability of suppliers for products in the clinical portfolio
  • Operate as the AZ Quality point of contact for Contract Manufacturers (CMOs) and Contract Testing Labs (CTLs)
  • Author and negotiate Quality-based agreements or sections of agreements (ESRs, Service Level Agreements, Quality Agreement) for CMOs, Clinical trials or Inter-company/Partner relationships with no oversight
  • Working knowledge of CFRs, EuDRA and associated guidances, regulations and annexes
  • Provide review of master and executed batch records and support disposition of material
  • Manage and assess Supplier Initiated Changes
  • Assist in Product Complaint an Non-Conformance investigations
  • Enforcement of contractual obligations
  • Maintain computerized documentation systems
  • Provide on-site support/oversight at CMOs
  • Understand contract language and the relevance to Quality
  • Conduct of due diligence, audits and/or inspections
  • Written and oral communication across multiple levels within AZ and at external suppliers
  • Participate in continuous improvement through the use of Lean tools and principles

Minimum Requirements:

  • B.A. or B.S. in Biology, Biochemistry, Chemistry, Engineering or related fields
  • 3+ years of industry experience
  • Supplier management experience
  • Drug Product process/product development experience
  • Drug Product manufacturing experience
  • M.S. in related field preferred

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

Apply Now


AstraZeneca Jobs – Apply for Clinical Pharmacometrician Jobs In Gaithersburg, Maryland

AstraZeneca Jobs in Gaithersburg:– Great news for job seekers. AstraZeneca Jobs site publish notice for various jobs vacancy in their offices. Currently AstraZeneca Clinical Pharmacometrician Jobs available now. Candidates who are looking for Clinical Pharmacometrician Jobs in Gaithersburg with relevant required experience can apply for AstraZeneca Jobs Employment. Candidate will get after selection great Salary $87,722.00 per year.

AstraZeneca Jobs in Gaithersburg Employment 

Name of the Recruitment Agencies/ Department: AstraZeneca

Name of the Vacant Position: Clinical Pharmacometrician

Job Location: Gaithersburg

Jobs Type: Jobs in Maryland

Salary: $87,722.00 per year

Full Job Description

Clinical Pharmacometrician in Respiratory & Immunology

Do you have experience and expertise in mathematical modelling and simulation, PKPD and its application in drug development? Do you also share our passion to explore possibilities of science to change lives? If yes, your next challenge might be this role at AstraZeneca!

This is an opportunity for a talented and engaged individual to join our growing Clinical Pharmacology and Quantitative Pharmacology team at AstraZeneca in Gaithersburg and develop as a Clinical Pharmacometrician supporting large and small molecule projects across full development within the therapy area of Respiratory & Immunology.

AstraZeneca is a world-leading pharmaceutical company, we focus on discovering and developing medicines that make a real difference to millions of patients. Within theClinical Pharmacology and Safety Sciences (CPSS) function, we have a state-of-the-art quantitative clinical pharmacology group with a diverse and uniquely skilled team of clinical pharmacometricians and clinical pharmacology scientists.

Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career.

What you’ll do:
You will work closely with clinical pharmacology scientists, physicians and other scientists and apply modelling to support the design and interpretation of clinical studies and influence key decisions in early and late clinical development.

The work includes integration of relevant data, such as dose information, pharmacokinetics, biomarkers and clinical endpoints within and across studies, compounds and development stages. Supporting informative trial designs using simulations and efficient modelling statistics is an important focus area for us. In collaboration with clinical pharmacology scientists, you’ll represent Clinical Pharmacology and Quantitative Pharmacology and be responsible for identifying and executing modelling to support model informed drug development. You will communicate your findings to other scientists within and outside of AstraZeneca and publish them in peer reviewed journals.

Requirements:

  • PhD or equivalent (M.Sc/Pharm.D.) level expertise in quantitative modelling , e.g. knowledge in mathematics and statistics applied to life sciences
  • Working knowledge of pharmacokinetics and its clinical application
  • Background and an understanding of clinical pharmacology aspects of drug development, preferably in both the small and large molecule setting
  • Experience with PK/PD analysis and statistical (pharmacometric) tools such as Phoenix Winnonlin, Nonmem, R
  • Biological understanding of disease and drug action
  • Good oral and written communication skills

Desirable for the role:

  • Recognized scientific expertise demonstrated by scientific publishing in the field of clinical pharmacology
  • Early or late phase clinical development experience/awareness.

Why AstraZeneca?

We are a global, science-led BioPharmaceutical business and our innovative medicines are used by millions of patients worldwide. It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.

Apply Now


AstraZeneca Jobs – Apply for Principal Scientist Jobs In Gaithersburg, Maryland

AstraZeneca Jobs in Gaithersburg:– Great news for job seekers. AstraZeneca Jobs site publish notice for various jobs vacancy in their offices. Currently AstraZeneca Principal Scientist Jobs available now. Candidates who are looking for Principal Scientist Jobs in Gaithersburg with relevant required experience can apply for AstraZeneca Jobs Employment. Candidate will get after selection great Salary $137,688.00 per year.

AstraZeneca Jobs in Gaithersburg Employment 

Name of the Recruitment Agencies/ Department: AstraZeneca

Name of the Vacant Position: Principal Scientist

Job Location: Gaithersburg

Jobs Type: Jobs in Maryland

Salary: $137,688.00 per year

Full Job Description

At AstraZeneca, we win through science, it’s at the heart of our every success. That science is only possible when we all work together – we’ll always make sure you’re clear about how your role is connected to our wider mission to really show what science can do!

As Principal Scientist you will be a member of the Integrated Bioanalysis team delivering Immunogenicity strategy,  scientific oversight, and regulatory interactions for AstraZeneca biologics including new modalities subject to preclinical and clinical studies, with focus on cell-based bioanalytical strategy, method development and validation, GxP Bioanalysis and Regulatory submission.

This position is located in Gaithersburg, MD

The AstraZeneca Gaithersburg campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This green, sustainable, modern, vibrant scientific campus is where we host some of the most cutting-edge technology and lab spaces. Newly designed, state of the art research spaces and open seating floor plans are just a couple of ways we work cross functionally and collaboratively.

The Gaithersburg campus also provides an award winning café, free garage parking with electric car charging stations, bike racks, free fitness center to include classed and personal training game rooms, outdoor patio, bocce ball court, arcade games and game tables, recharge Pod’s, library, walking trails, onsite dry cleaning pickup, haircutting service, health and wellness center, starbucks café, and much more!

Position Responsibilities:

  • Lead cell-based immunogenicity assay development, validation and bioanalysis for all biotherapeutics including cell and gene therapies. Supervise and mentor laboratory scientists in designing, developing and validating cell-based bioanalytical assays.
  • Review and approve bioanalytical data and reports to ensure quality and integrity. Contribute to regulatory document preparation including responses and submissions.
  • As cell based assay expert, work closely with clinical teams and bioanalytical teams for immunogenicity assessment and ADA assay strategies.
  • Supervise transfer and validation of developed neutralizing ADA assays to CROs. Work closely with outsourcing team to ensure high quality and timely delivery for the method setup and sample analysis.
  • Stay current on the immunogenicity assessment and neutralizing ADA assay techniques. Propose and implement new techniques as well as strategies and practices that are in line with industry practices and regulatory requirements.
  • Establish internal and external influence through initiatives, consortium activities, presentations, and publications.
  • Hire and retain talent, develop junior scientists in scientific and professional growth.
  • Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulation.

Education/Experience requirements:

  • PhD in Immunology, Cell Biology, Biochemistry, or related discipline
  • 7 or more years of cell-based immunogenicity assay experience in the pharmaceutical industry or CRO.

Essential Skills:

  • Strong background in the development and validation of immunochemical and cell-based assays to regulatory standards, including experience with cell culture techniques, ELISA, MSD and other novel technologies.
  • Strong knowledge of industry practices and regulatory guidance for the development, qualification/ validation of immunogenicity assays, including cell-based and competitive ligand binding assay-based neutralizing ADA assays.
  • Experience with complex biologics including multi-domains and new modalities such as cell and gene therapies.
  • Experience with regulatory documents and submissions
  • Experience managing individual contributors.
  • Laboratory experience with GLP regulations, GxP documentation and regulatory guidance.
  • Detail oriented, good documentation practices, technical writing and verbal communication skills.
  • Ability to handle multiple projects and/or tasks in a fast-paced environment.

Benefits:

AstraZeneca is a leading company in the healthcare industry, with a mission to enrich the lives of others. It’s our business to support healthy living, not only for our patients, but also for our employees. Our benefits program is flexible enough to meet employees’ varying needs, offers valuable choices, and is highly competitive.AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial – finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together.

Come and join our journey –  Apply today!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

Apply Now

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